Stroke
Conditions
Keywords
stroke, Lower Extremity, Walking
Brief summary
The main purpose of this clinical trial is to evaluate the effectiveness and safety of the MI-R1 walking machine in lower limb motor function training for stroke patients. The main question is to answer: 1. Are patients using MI-R1 lower limb walking machine training more effective than those using traditional rehabilitation training? 2. Is the MI-R1 lower limb walking machine safe? Participants will: 1. The experimental group received MI-R1 lower limb walking machine assisted training, while the control group received traditional rehabilitation training. 2. Perform functional testing on the 0th, 14th, and 28th day of training. 3. Observe whether there is any discomfort or safety during the rehabilitation training process.
Interventions
DEVICEMI-R1 lower limb walking machine assisted training device
The training is conducted under partial weight support training conditions, performing passive movements on the lower limbs through motor drive, improving the joint activity of the patient's hip and knee joints, and achieving sitting, standing, and walking functions.
OTHERWalking rehabilitation training under the guidance of therapists
Each patient undergoes training under the guidance of a rehabilitation therapist
Sponsors
Zhejiang Hospital
Zhejiang Provincial Tongde Hospital
Zhejiang University
Sir Run Run Shaw Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients diagnosed with stroke through CT or MRI, and only accompanied by hemiplegia on one side, with first-time onset or previous episodes without residual neurological dysfunction; * Vital signs stable, neurological symptoms no longer aggravate after 48 hours, no severe cognitive impairment or aphasia, and cooperate with training; * Modified Ashworth score for lower limb ≤ level 2, standing balance function level ≥1; * Voluntarily participating in this trial, understanding and cooperating with the entire trial process, and signing a written informed consent form.
Exclusion criteria
* Bone, joint, muscle disease, or lower limb disabilities (such as severe osteoporosis, fractures, spinal instability, severely limited joint range of motion, severe limb muscle contractures, deformities, etc.) or diseases that affect balance and walking; * Stroke caused by cerebellar brainstem injury and cortical injury; * Patients with severe primary diseases such as cardiovascular, pulmonary, hepatic, renal, and hematopoietic systems, as well as critically ill and psychiatric patients; * Other contraindications or complications that may affect walking training treatment; * Patients with local skin damage or pressure ulcers in the lower limbs; * Patients with peripheral nerve injury in the lower limbs; * Inappropriate body shape for robots (height\<150cm or\>190cm, or weight\>85 kg); * Planned pregnancy or pregnant and lactating women; * Participants in other clinical trials within the past 3 months; * Severe cognitive impairment; * Known refusal or inability to comply with protocol requirements for any reason (including planned clinical visits and examinations); * The researchers believe that it should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day | through study completion, an average of one and a half year | Lower limb function assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day | through study completion, an average of one and a half year | Lower limb function assessment |
| Holden Walking Function Classification | through study completion, an average of one and a half year | Pedestrian function assessment on the 0th，14th and 28th day |
| Modified Barthel Index | through study completion, an average of one and a half year | Assessment of activities of daily living ability on the 0th，14th and 28th day |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vital signs - pulse | through study completion, an average of one and a half year | Measure the patient's pulse on the 0th, 14th, and 28th days of training |
| Vital signs - temperature | through study completion, an average of one and a half year | Measure the patient's body temperature on the 0th, 14th, and 28th days of training |
| Device defects checklist | through study completion, an average of one and a half year | The risks to health and safety that may arise from the normal use of medical devices, including quality and malfunctions |
| Adverse events | through study completion, an average of one and a half year | Number of participants with treatment-related adverse events as assessed by Criteria for determining adverse events |
| Vital signs - heart rate | through study completion, an average of one and a half year | Measure the patient's heart rate on the 0th, 14th, and 28th days of training |
| Vital signs - respiratory rate | through study completion, an average of one and a half year | Measure the patient's respiratory rate on the 0th, 14th, and 28th days of training |
| Vital signs - blood pressure | through study completion, an average of one and a half year | Measure the patient's blood pressure on the 0th, 14th, and 28th days of training |
Countries
China
Outcome results
None listed